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Approved Drug Products containing Buprenorphine listed in the FDA Orange Book. Original Data : FDA Website

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01 5ALVOGEN

02 5AMNEAL

03 5AVEVA

04 7BRAEBURN

05 2INDIVIOR

06 5MYLAN TECH VIATRIS

07 5PURDUE PHARMA LP

08 5WATSON LABS TEVA

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PharmaCompass

01

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BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 5MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

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BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 10MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 15MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 20MCG/HR

Approval Date : 2018-11-20

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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BUPRENORPHINE

Brand Name : BUPRENORPHINE

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 7.5MCG/HR

Approval Date : 2021-06-29

Application Number : 204937

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 5MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 10MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 20MCG/HR

Approval Date : 2010-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 15MCG/HR

Approval Date : 2013-07-25

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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BUPRENORPHINE

Brand Name : BUTRANS

Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

Dosage Strength : 7.5MCG/HR

Approval Date : 2014-06-30

Application Number : 21306

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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